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Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening (E-CAP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02529007
First Posted: August 19, 2015
Last Update Posted: May 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Portsmouth Hospitals NHS Trust
  Purpose
The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a colonoscope improves the numbers of polyps detected during bowel cancer screening colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy with the cap attached.

Condition Intervention
Colonic Polyps Colonic Neoplasms Device: Endo-cuff Other: Standard colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Endo-cuff Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening Patients: A Randomised Controlled Trial. The E-CAP Study

Resource links provided by NLM:


Further study details as provided by Portsmouth Hospitals NHS Trust:

Primary Outcome Measures:
  • Number of polyps detected per patient [ Time Frame: 1 month (when pathology report available) ]

Secondary Outcome Measures:
  • Cancer detection rate [ Time Frame: 1 month (when pathology report available) ]
  • Polyp detection rate [ Time Frame: 1 month (when pathology report available) ]
  • Adenomas per patient [ Time Frame: 1 month (when pathology report available) ]
  • Adenoma detection rate [ Time Frame: 1 month (when pathology report available) ]
  • Caecal intubation rate [ Time Frame: 1 day ]
    will be recorded at the time of the procedure

  • Total procedure time - from scope insertion to removal [ Time Frame: 1 day ]
    will be recorded at the time of the procedure

  • Time taken to reach caecum [ Time Frame: 1 day ]
    will be recorded at the time of the procedure

  • Time taken to withdraw scope (from caecum to removal of scope) [ Time Frame: 1 day ]
    will be recorded at the time of the procedure

  • Patient comfort score [ Time Frame: 1 day ]
    will be recorded at the time of the procedure


Enrollment: 534
Study Start Date: September 2014
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard
These patients have standard colonoscopy performed
Other: Standard colonoscopy
Standard colonoscopy without end-cuff
Experimental: Endocuff
These patients have colonoscopy performed with the endo-cuff attached to the end of the colonoscope
Device: Endo-cuff
Colonoscopy performed with endo-cuff attached to the colonoscope

Detailed Description:

Problem statement:

In England, everyone in the age group of 60-69 years is invited to participate in bowel cancer screening. Those who test positive in the initial screening stool test are invited to have a colonoscopy. The purpose of colonoscopy is to detect any obvious cancers, and in the absence of obvious cancers the purpose is to detect and remove all the polyps present in the colon, as polyps have the potential to develop into cancers. However, colonoscopy still misses up to 25% of polyps. Cap assisted colonoscopy improves polyp detection but still misses a significant number of polyps. There is a need for an improved cap design which will help improve polyp detection.

Research question/hypothesis:

Does using an endocuff on a colonoscope improve polyp detection as compared to standard colonoscopy in bowel cancer screening patients?

Study design:

Parallel group, single blinded randomised controlled trial

Study participants:

Patients attending for colonoscopy under the bowel cancer screening programme

Planned sample size: 534

Planned study period: 12 months

Primary objective:

To assess the impact of endocuff assisted colonoscopy on the number of polyps detected per patient

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients referred for colonoscopy under the national bowel cancer screening programme
  • Able to provide written informed consent

Exclusion Criteria:

  • History of Inflammatory bowel disease
  • History of Hereditary non polyposis colorectal cancer
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02529007


Locations
United Kingdom
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Sponsors and Collaborators
Portsmouth Hospitals NHS Trust
Investigators
Principal Investigator: Pradeep Bhandari, MBBS, MD, MRCP Portsmouth Hospitals NHS Trust
  More Information

Responsible Party: Portsmouth Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02529007     History of Changes
Other Study ID Numbers: PHT/2013/71
First Submitted: July 17, 2015
First Posted: August 19, 2015
Last Update Posted: May 30, 2016
Last Verified: July 2015

Keywords provided by Portsmouth Hospitals NHS Trust:
Colonoscopy
early cancer detection
cancer screening

Additional relevant MeSH terms:
Polyps
Colonic Polyps
Colonic Neoplasms
Pathological Conditions, Anatomical
Intestinal Polyps
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases